Expiration of Drug Testing

Circular 11 stipulates the testing period starting from the time the first batch of drugs is imported after the Ministry of Health (Drug Administration) announces the List of Manufacturers with Quality Violations as follows:

- 06 months for manufacturers with 01 batch of drugs violating level 3;- 12 months for manufacturers with 01 batch of drugs violating level 2 or from 02 batches of drugs violating level 3 and above;- 24 months for manufacturers with 01 batch of drugs violating level 1 or from 02 batches of drugs violating level 2 and above;- Particularly, in cases where the manufacturer continues to have quality violations, the conduction period of testing is extended by cumulative method.

Additionally, Circular 11 also stipulates the conditions for manufacturers to be removed from the List of Manufacturers with Quality Violations when fully meeting the following regulations:

- The importer conducts full drug testing before circulating according to the prescribed period;- The manufacturer or the drug registration establishment reports in accordance with the regulations and provides evidence of conducting testing on all batches of drugs imported into Vietnam within the prescribed period;- The manufacturer does not have any quality violations (including voluntary drug recalls for quality reasons) within the prescribed period.

Monthly, based on reports from testing establishments participating in the testing activities, reports from the manufacturer, drug registration establishment, the Ministry of Health (Drug Administration) will update and announce the List of Manufacturers with Quality Violations, removing manufacturers that meet the regulations from the List.

See details at Circular 11/2018/TT-BYT effective from June 20, 2018.

-Thao Uyen-

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